Safety Scientist (Pharmacovigilance)

Roles & Responsibilities
• Perform safety surveillance, signal detection, risk minimization, and safety data evaluation
• Author, review, and support delivery of aggregate safety reports (ASRs), DSURs, and PSURs
• Draft safety management plans and signal detection plans
• Support internal and client-facing safety strategy development
• Prepare and update regulatory safety documents including RMPs, REMS, and CCDS/CCSI
• Review safety sections of study protocols and assess ICSRs for completeness and accuracy
• Maintain pharmacovigilance system master file (PSMF) and related documentation
• Define search strings and conduct safety-related literature searches and analysis
• Generate reports to support EMA medical literature monitoring requirements
• Collaborate with cross-functional teams to ensure accurate source data review and analysis

Qualification
• B.Pharm / M.Pharm
• Life Sciences (Biochemistry, Biotechnology, Pharmacology, Microbiology)
• Biomedical Science, Nursing, Chemistry, Biology

Experience
• 3 to 7 years of pharmacovigilance / drug safety / clinical trials experience
• Strong understanding of global PV regulations and guidelines (ICH-GCP, EMA, USFDA)
• Experience in data analysis, document review, and cross-functional stakeholder communication

Skills
• Safety signal detection and risk management
• Aggregate report writing (DSUR, PSUR/PBRER, ASR)
• Regulatory safety documentation (RMP, REMS, CCDS/CCSI)
• ICSR and protocol safety section review
• PSMF maintenance and PV compliance documentation
• Medical literature search strategy, analysis, and reporting
• Strong written communication and stakeholder management

About The Company
ICON plc is a global clinical research organization supporting drug development and lifecycle management across therapeutic areas. ICON partners with sponsors to deliver clinical trials and pharmacovigilance solutions, with a focus on quality, regulatory compliance, and patient safety worldwide.